Aerogen Ltd.
DANGAN Galway, IE
AEROGEN LTD. appears in FDA device records in DANGAN Galway, IE. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Aerogen Ltd. between 2000 and 2025. The busiest year on record is 2000, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | SFP | Substantially Equivalent | |
| K232507 | Aerogen®Solo Nebulizer System | CAF | Substantially Equivalent | |
| K143719 | Aeroneb USB Contoller System | CAF | Substantially Equivalent | |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | CAF | Substantially Equivalent | |
| K120939 | AERONEB PRO | CAF | Substantially Equivalent | |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | CAF | Substantially Equivalent | |
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 | CAF | Substantially Equivalent | |
| K021175 | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 | CAF | Substantially Equivalent | |
| K003022 | AERONEB PORTABLE NEBULIZER | CAF | Substantially Equivalent | |
| K992831 | AERONEB II, MODEL APN 200 | CAF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004127293 | 3004127293 | AEROGEN LTD. | M&M QUALTECH, PARKMORE, GALWAY Galway(County) -- IE | 2026 | |
| 3003399703 | 3003399703 | AEROGEN LTD | GALWAY BUSINESS PARK, DANGAN Galway(County) -- IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0121-2015 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. | Class II | Terminated | |
| Z-0120-2015 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. | Class II | Terminated | |
| Z-0119-2015 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. | Class II | Terminated | |
| Z-0118-2015 | The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers. | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain